The Effect of Meal Replacement Therapy on Glucose Control and Other Metabolic Parameters in Patients With Uncontrolled Type 2 Diabetes on Oral Hypoglycemic Agents: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- To compare changes and differences of HbA1c over a 12-week period in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.
研究概览
简要总结
To evaluate the effect of meal replacement therapy on glucose control and other metabolic parameters in patients with uncontrolled type 2 diabetes.
Methodology:
This is an open-label, prospective, randomized control trial study. Study duration. August 2023 - March 2026. Study location. This study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia.
Source Reference :
People with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia.
Study source population :
People with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period.
详细描述
General objective To determine the effect of Contro Eazy NOW (CEN) as meal replacement therapy on HbA1c, fasting plasma glucose, fasting lipid profile, body mass index (BMI) and body composition in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents vs control group.
Hypotheses
- There are significant improvement in HbA1c over a 12-week period between type 2 diabetes mellitus patients taking meal replacement Contro Eazy Now vs the control group (between-group).
- There are significant improvement in HbA1c among type 2 diabetes mellitus patients at baselines and 12-week after taking meal replacement Contro Eazy Now (within-group).
- There are significant improvements in fasting plasma glucose, fasting lipid profile, body mass index (BMI), blood pressure body composition (muscle mass(kg), fat mass (kg), fat percentage (%) and diabetes quality of life over 12-weeks between type 2 diabetes mellitus patients taking meal replacement Contro Eazy Now vs control group (between-group).
- There are significant improvements in fasting plasma glucose, fasting lipid profile, body mass index (BMI), blood pressure, body composition (muscle mass(kg), fat mass (kg), fat percentage (%) and diabetes quality of life at baselines and 12-week after taking meal replacement Contro Eazy Now? (within-group).
Study procedure Participants will be recruited from KRK. Potential participants will be identified from the case notes of patients or being referred by the medical officers in charge. Participants will be screened to determine their eligibility criteria. Those who are willing to participate in this study will be given information regarding the study. Informed consent will be obtained. Their latest blood result within the last 3 months will be checked such as hemoglobin A1c (HbA1c), Liver function test (LFT), renal function test (RFT). If there is no blood result within the last 3 months, blood will be taken and sent to the private lab.
If all the inclusion criteria are fulfilled, they will be given an appointment for the next visit for recruitment. During recruitment, the participants' socio-demographic data will be collected, and the medical record will be assessed to fill in their medical and diabetes profiles. They will also answer the Diabetes Quality of Life (Rv-DQoL) questionnaire. The physical examination includes measurement of height, weight, calculated Body Mass Index (BMI), body composition (muscle mass, fat mass and fat percentage) and blood pressure during sitting will be done. Blood taking 8ml of fasting venous blood will be taken for measurement of hemoglobin A1c (HbA1c), fasting blood sugar(FBS), full blood count(FBC), renal function test(RFT), liver function test(LFT) and fasting lipid profile(FLP) as a baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between ≥ 30 to ≤ 65 years old
- •Diagnosed as having type 2 diabetes mellitus base on CPG Malaysia Clinical Practice Guidelines (CPG) for Type 2 Diabetes Mellitus (T2DM) 6th edition
- •On oral hypoglycaemic agent(s)
- •HbA1c 7- 10 % (result 3 months from the date of recruitment)
- •Agree not to take other beverages, herbal or nutritional supplements for the duration of the study.
排除标准
- •Severe diabetic complication(s) including end-stage renal disease and proliferative retinopathy.
- •Pregnancy or plan to get pregnant during the study period
- •Newly diagnosed diabetic less than 3 months from the date of recruitment
- •Currently involve in any weight loss program
- •Currently consuming any meal replacement product
- •Patients with chronic kidney disease with eGFR ≤ 25 ml/min.
- •Patients with advanced liver disease, such as non-alcoholic steatohepatitis (NASH) with significant fibrosis (e.g., liver stiffness measurement > 9.5 kPa by FibroScan) or cirrhosis.
- •Patients with significantly elevated liver enzymes (e.g., ALT or AST ≥ 3 times the upper limit of normal), which may indicate more severe liver damage.
结局指标
主要结局
To compare changes and differences of HbA1c over a 12-week period in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.
时间窗: 12 weeks
The HbA1c test reflects the average blood glucose levels by measuring the percentage of glycated hemoglobin (hemoglobin bound with glucose) and is an important indicator of long term blood sugar control. The HbA1c results are reported as a percentage (%) of glycated hemoglobin. The target HbA1C level for most diabetic individuals is typically below 7% to reduce the risk of diabetes-related complications.
次要结局
- To compare changes and differences in diabetes quality of life in patients with type 2 diabetes mellitus in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.(12 weeks.)
- To monitor meal replacement related adverse events in participants who are in the intervention group over the study period.(12 weeks)
- To compare changes and differences in body composition fat mass (kg) in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.(12 weeks)
- To compare changes and differences in fasting plasma glucose, in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.(12 weeks)
- To compare changes and differences in fasting plasma glucose, in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement (within group).(12 weeks)
- To compare changes and differences in fasting lipid profile in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement (within group).(12 weeks)
- To compare changes and differences in body mass index (BMI), in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement within group.(12 weeks.)
- To compare changes and differences in body composition (muscle mass(kg), fat mass (kg) and fat in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement within group.(12 weeks.)
- To compare changes and differences in fasting lipid profile in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.(12 weeks)
- To compare changes and differences in body mass index (BMI), in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.(12 weeks.)
- To compare changes and differences in body composition (muscle mass(kg), in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.(12 weeks)
- To compare changes and differences in diabetes quality of life in patients with type 2 diabetes mellitus in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement within group.(12 weeks)
研究者
Kanmani Kumaran
Dr
Hospital Universiti Sains Malaysia